FDAFDA · Food and drugs·Recall number D-855-2013
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Published August 14, 2013 · Recall initiated: July 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: CG2D18A, Exp 06/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States